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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Rheumatoid Factor
510(k) Number K851537
Device Name LASER RF CONTROL SERUM-QUALITY CONTROL SERUM
Applicant
Behring Diagnostics, Inc.
10933 No Torrey Pines Rd.
La Jolla,  CA  92037
Applicant Contact JOHN E HUGHES
Correspondent
Behring Diagnostics, Inc.
10933 No Torrey Pines Rd.
La Jolla,  CA  92037
Correspondent Contact JOHN E HUGHES
Regulation Number866.5775
Classification Product Code
DHR  
Date Received04/16/1985
Decision Date 06/05/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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